EMA Scientific Advice for High-Risk Devices – What We Know So Far

Description: The regulatory landscape for medical devices in the EU continues to evolve with stricter requirements and higher expectations, especially for what concerns clinical evidence. There is therefore a growing need for a system providing some early feedback to manufacturers on their clinical strategies. With this objective, a pilot was launched in 2023 to provide scientific advice per MDR article 61(2) to ten manufacturers of class III and certain class IIb devices.

The activities of the expert panel in charge of such activity are coordinated by the European Medicine Agency (EMA) and are currently ongoing. This session will provide an overview of the objectives, status, methods, and lessons learnt directly from EMA so as the plans for a future implementation of the system after the pilot phase.

The session will also provide the first-hand experience of a manufacturer undergoing the process.